DifGen Pharmaceuticals, in collaboration with Apotex, announced that the FDA has granted final approval for the Abbreviated New Drug Application (ANDA) for Nintedanib Soft Gel Capsules, 100 mg and 150 mg. The approved products are therapeutically equivalent (AB-rated) to Ofev®, the reference listed drug indicated for idiopathic pulmonary fibrosis, chronic fibrosing interstitial lung diseases, and systemic sclerosis-associated interstitial lung disease.
Under the partnership, Apotex Corp. will market and distribute the generic Nintedanib capsules across the U.S. healthcare market. The approval marks a key milestone in DifGen’s strategy to expand its portfolio of complex generic products and to strengthen its position in advanced soft gelatin dosage forms.
“This milestone reflects DifGen’s technical capabilities in developing complex soft gelatin drug products and the strength of our development and quality systems,” said Ramandeep Singh Jaj and Dr. Santhanakrishnan Srinivasan, Co-Founders and Co-CEOs of DifGen Pharmaceuticals. “We remain focused on executing a compliant and reliable commercialization strategy in collaboration with our partners.”
Christine Baeder, President of Apotex U.S. and LATAM, added, “Apotex looks forward to commercializing this important product for the American patient. The introduction of Nintedanib reflects our Journey of Health Strategy, aimed at expanding treatment options and reducing barriers to care.”
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